A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® (Kronos)
NCT ID: NCT02497001
Last Updated: 2020-12-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1902 participants
INTERVENTIONAL
2015-08-10
2018-01-05
Brief Summary
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Detailed Description
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This study includes the following 3 sub-studies: 12-hour Pulmonary Function Test (PFT), Pharmacokinetic (PK) Profile, and Hypothalamic-pituitary-adrenal Axis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BGF MDI (PT010) 320/14.4/9.6 μg ex-actuator
BGF MDI 320/14.4/9.6 μg,Budesonide, Glycopyrronium, Formoterol Fumarate Inhalation Aerosol
BGF MDI 320/14.4/9.6 μg
Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (PT010, BGF metered dose inhaler \[MDI\])
GFF MDI (PT003) 14.4/9.6 μg ex-actuator
GFF MDI 14.4/9.6 μg ex-actuator Glycopyrronium, Formoterol Fumarate Inhalation Aerosol
GFF MDI (PT003) 14.4/9.6 μg
Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI)
BFF MDI (PT009) 320/9.6 μg ex-actuator
BFF MDI 320/9.6 μg, Budesonide, Formoterol Fumarate Inhalation Aerosol
BFF MDI (PT009) 320/9.6 μg
Budesonide and Formoterol Fumarate Inhalation Aerosol (PT009, BFF MDI)
Symbicort
Symbicort® Turbuhaler® (TBH) Inhalation Powder 200/6 μg
Symbicort® Turbuhaler® (TBH) Inhalation Powder
Interventions
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BGF MDI 320/14.4/9.6 μg
Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (PT010, BGF metered dose inhaler \[MDI\])
GFF MDI (PT003) 14.4/9.6 μg
Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI)
BFF MDI (PT009) 320/9.6 μg
Budesonide and Formoterol Fumarate Inhalation Aerosol (PT009, BFF MDI)
Symbicort® Turbuhaler® (TBH) Inhalation Powder
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study.
* Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS), or other local applicable guidelines.
* Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
* Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) ratio must be \<0.70 and FEV1 must be \<80% predicted normal value calculated using NHANES III reference equations (or reference norms applicable to other regions).
* Required COPD maintenance therapy:
* All Subjects must have been on two or more inhaled maintenance therapies for the management of their COPD for at least 6 weeks prior to Screening. Scheduled SABA and/or scheduled SAMA are considered inhaled maintenance therapies
Exclusion Criteria
* Women who are pregnant or lactating, or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception.
* Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
* Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening) or during the Screening Period
* Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Visit 1 (Screening) or during the Screening Period
* Immune suppression or severe neurological disorders affecting control of the upper airway or other risk factors that in the opinion of the Investigator would put the subject at substantial risk of pneumonia.
* Subjects with a diagnosis of narrow angle glaucoma, who, in the opinion of the Investigator, have not been adequately treated.
* Subjects who have a history of hypersensitivity to β2-agonists, budesonide or any other corticosteroid components, glycopyrronium or other muscarinic anticholinergics, or any other component of the IMPs.
40 Years
80 Years
ALL
No
Sponsors
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Pearl Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Dorinsky, MD
Role: STUDY_DIRECTOR
Pearl Therapeutics, Inc.
Locations
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Research Site
Andalusia, Alabama, United States
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Jasper, Alabama, United States
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Peoria, Arizona, United States
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Phoenix, Arizona, United States
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Fullerton, California, United States
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Gold River, California, United States
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Poway, California, United States
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Rolling Hills Estates, California, United States
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Sacramento, California, United States
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Clearwater, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Ormond Beach, Florida, United States
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Pensacola, Florida, United States
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Tamarac, Florida, United States
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Tampa, Florida, United States
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Winter Park, Florida, United States
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Dacula, Georgia, United States
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Norcross, Georgia, United States
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Rincon, Georgia, United States
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Edina, Minnesota, United States
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Minneapolis, Minnesota, United States
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Minneapolis, Minnesota, United States
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Woodbury, Minnesota, United States
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Saint Charles, Missouri, United States
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St Louis, Missouri, United States
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Reno, Nevada, United States
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Albuquerque, New Mexico, United States
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Charlotte, North Carolina, United States
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Gastonia, North Carolina, United States
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Greensboro, North Carolina, United States
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Hendersonville, North Carolina, United States
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Mooresville, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Dublin, Ohio, United States
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Medford, Oregon, United States
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Anderson, South Carolina, United States
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Charleston, South Carolina, United States
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Easley, South Carolina, United States
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Greenville, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Old Point Station, South Carolina, United States
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Rock Hill, South Carolina, United States
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Seneca, South Carolina, United States
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Spartanburg, South Carolina, United States
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Union, South Carolina, United States
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Johnson City, Tennessee, United States
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Kingwood, Texas, United States
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Longview, Texas, United States
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San Antonio, Texas, United States
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Abingdon, Virginia, United States
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Newport News, Virginia, United States
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Richmond, Virginia, United States
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Richmond, Virginia, United States
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Tacoma, Washington, United States
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Morgantown, West Virginia, United States
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Truro, Nova Scotia, Canada
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Greater Sudbury, Ontario, Canada
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Mississauga, Ontario, Canada
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Toronto, Ontario, Canada
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Mirabel, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Québec, , Canada
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Anqing, , China
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Baotou, , China
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Changchun, , China
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Changsha, , China
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Changsha, , China
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Guangzhou, , China
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Guangzhou, , China
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Guangzhou, , China
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Guangzhou, , China
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Haikou, , China
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Hangzhou, , China
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Heshan, , China
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Hohhot, , China
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Hohhot, , China
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Jinan, , China
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Lianyungang, , China
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Linhai, , China
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Nanchang, , China
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Pingxiang, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Shengyang, , China
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Shenyang, , China
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Shenyang, , China
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Taiyuan, , China
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Tianjin, , China
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Ürümqi, , China
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Wenzhou, , China
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Wuhan, , China
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Wuxi, , China
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Xuzhou, , China
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Yangzhou, , China
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Zhuhai, , China
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Bunkyō City, , Japan
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Chūōku, , Japan
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Chūōku, , Japan
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Chūōku, , Japan
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Date-gun, , Japan
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Fukuoka, , Japan
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Ginowan-shi, , Japan
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Hakata-shi, , Japan
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Hamamatsu, , Japan
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Hamamatsu, , Japan
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Hamamatsu, , Japan
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Higashiokitama-gun, , Japan
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Higashiosaka-shi, , Japan
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Himeji-shi, , Japan
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Hirakata-shi, , Japan
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Iizuka-shi, , Japan
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Itabashi-ku, , Japan
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Iwata-shi, , Japan
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Izumo-shi, , Japan
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Izumo-shi, , Japan
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Kagoshima, , Japan
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Kahoku-gun, , Japan
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Kakogawa-shi, , Japan
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Kasaoka-shi, , Japan
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Kasuga-shi, , Japan
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Kishiwada-shi, , Japan
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Kiyose-shi, , Japan
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Kobe, , Japan
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Koga-shi, , Japan
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Kurashiki-shi, , Japan
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Kure-shi, , Japan
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Kure-shi, , Japan
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Kyoto, , Japan
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Kyoto, , Japan
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Kyoto, , Japan
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Kyoto, , Japan
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Kyoto, , Japan
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Maebashi, , Japan
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Matsumoto-shi, , Japan
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Matsusaka-shi, , Japan
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Meguro-ku, , Japan
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Mitaka-shi, , Japan
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Mizunami-shi, , Japan
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Nagaoka-shi, , Japan
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Nagoya, , Japan
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Nagoya, , Japan
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Nagoya, , Japan
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Naha, , Japan
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Nishishirakawa-gun, , Japan
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Obihiro-shi, , Japan
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Ogaki-shi, , Japan
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Okinawa-shi, , Japan
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Ookawa-shi, , Japan
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Osaka, , Japan
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Osakasayama-shi, , Japan
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Ōita, , Japan
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Ōita, , Japan
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Ōtsu, , Japan
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Sakaide-shi, , Japan
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Sakaishi, , Japan
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Sapporo, , Japan
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Sapporo, , Japan
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Sendai, , Japan
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Sendai, , Japan
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Sendai, , Japan
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Seto-shi, , Japan
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Shinagawa-ku, , Japan
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Shinjuku-ku, , Japan
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Shizuoka, , Japan
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Suita-shi, , Japan
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Tachikawa-shi, , Japan
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Takamatsu, , Japan
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Toon-shi, , Japan
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Toshima-ku, , Japan
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Toyama, , Japan
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Toyama, , Japan
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Toyama, , Japan
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Yanagawa-shi, , Japan
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Yokohama, , Japan
Countries
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References
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Singh D, Bafadhel M, Arya N, Marshall J, Parikh H, Kisielewicz D, Movitz C, Bowen K, Patel M. Step up to triple therapy versus switch to dual bronchodilator therapy in patients with COPD on an inhaled corticosteroid/long-acting beta2-agonist: post-hoc analyses of KRONOS. Respir Res. 2025 May 8;26(1):175. doi: 10.1186/s12931-025-03234-5.
Muro S, Seki M, Hurst JR, Petullo D, Marshall J, Bowen K, Darken PF, Duncan EA, Megally A, Patel M. Triple Therapy with Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate versus Dual Therapies for Patients with COPD and Phenotypic Features of Asthma: A Pooled Post Hoc Analysis of KRONOS and ETHOS. Int J Chron Obstruct Pulmon Dis. 2024 Dec 12;19:2729-2737. doi: 10.2147/COPD.S478349. eCollection 2024.
Muro S, Kawayama T, Sugiura H, Seki M, Duncan EA, Bowen K, Marshall J, Megally A, Patel M. Benefits of budesonide/glycopyrronium/formoterol fumarate dihydrate on lung function and exacerbations of COPD: a post-hoc analysis of the KRONOS study by blood eosinophil level and exacerbation history. Respir Res. 2024 Aug 5;25(1):297. doi: 10.1186/s12931-024-02918-8.
Singh D, Hurst JR, Martinez FJ, Rabe KF, Bafadhel M, Jenkins M, Salazar D, Dorinsky P, Darken P. Predictive modeling of COPD exacerbation rates using baseline risk factors. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221107314. doi: 10.1177/17534666221107314.
Liu J, He X, Wu J. Economic Evaluation of Triple Therapy with Budesonide/Glycopyrrolate/Formoterol Fumarate for the Treatment of Moderate to Very Severe Chronic Obstructive Pulmonary Disease in China Using a Semi-Markov Model. Appl Health Econ Health Policy. 2022 Sep;20(5):743-755. doi: 10.1007/s40258-022-00732-1. Epub 2022 Apr 28.
Muro S, Sugiura H, Darken P, Dorinsky P. Efficacy of budesonide/glycopyrronium/formoterol metered dose inhaler in patients with COPD: post-hoc analysis from the KRONOS study excluding patients with airway reversibility and high eosinophil counts. Respir Res. 2021 Jun 28;22(1):187. doi: 10.1186/s12931-021-01773-1.
Huang Y, Assam PN, Feng C, Su R, Dorinsky P, Gillen M. Ethnic pharmacokinetic comparison of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI) between Asian and Western healthy subjects. Pulm Pharmacol Ther. 2020 Oct;64:101976. doi: 10.1016/j.pupt.2020.101976. Epub 2020 Nov 2.
Wang C, Yang T, Kang J, Chen R, Zhao L, He H, Assam PN, Su R, Bourne E, Ballal S, DeAngelis K, Dorinsky P. Efficacy and Safety of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler in Chinese Patients with COPD: A Subgroup Analysis of KRONOS. Adv Ther. 2020 Apr;37(4):1591-1607. doi: 10.1007/s12325-020-01266-5. Epub 2020 Mar 6.
Ichinose M, Fukushima Y, Inoue Y, Hataji O, Ferguson GT, Rabe KF, Hayashi N, Okada H, Takikawa M, Bourne E, Ballal S, DeAngelis K, Aurivillius M, Reisner C, Dorinsky P. Long-Term Safety and Efficacy of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Formulated Using Co-Suspension Delivery Technology in Japanese Patients with COPD. Int J Chron Obstruct Pulmon Dis. 2019 Dec 23;14:2993-3002. doi: 10.2147/COPD.S220861. eCollection 2019.
Dunn LJ, Kerwin EM, DeAngelis K, Darken P, Gillen M, Dorinsky P. Pharmacokinetics of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler formulated using co-suspension delivery technology after single and chronic dosing in patients with COPD. Pulm Pharmacol Ther. 2020 Feb;60:101873. doi: 10.1016/j.pupt.2019.101873. Epub 2019 Dec 10.
Ferguson GT, Rabe KF, Martinez FJ, Fabbri LM, Wang C, Ichinose M, Bourne E, Ballal S, Darken P, DeAngelis K, Aurivillius M, Dorinsky P, Reisner C. Triple therapy with budesonide/glycopyrrolate/formoterol fumarate with co-suspension delivery technology versus dual therapies in chronic obstructive pulmonary disease (KRONOS): a double-blind, parallel-group, multicentre, phase 3 randomised controlled trial. Lancet Respir Med. 2018 Oct;6(10):747-758. doi: 10.1016/S2213-2600(18)30327-8. Epub 2018 Sep 16.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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Other Identifiers
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PT010006
Identifier Type: -
Identifier Source: org_study_id